What is MDDS?
A new classification regulation effective February 2011
21 CFR 880.6310 - Medical device data system
Initial MDDS registration was required by May 16th, 2011
MDDS will be actively enforced beginning April 18th, 2012 through
on-site FDA inspections
Medical device data is electronic data that originates from a medical
device
MDDS reclassifies data systems that electronically:
Transfer, store, convert or display medical device data
Includes software, electronic or electrical hardware (including wireless),
modems, interfaces and communication protocols
MDDS does not include devices intended to be used in connection with
active patient monitoring
MDDS Facts
Medical device data always originates from a medical device
Labeling can partially define the regulated system – i.e., what uses are
claimed
An MDDS may be a single component (storage, display, communication
component), or any combination of these components
An MDDS can initiate and control communication
Data transmitted through an MDDS can control a device, but the control command must have
originated from another device
An MDDS can facilitate communication, but may not alter the data in transit
Potential MDDS or MDDS+ Systems
Bedside data displays
Customization to commercially purchased systems
Work flow “wrappers”
Clinical decision support systems
IV Pump, Infusion, Dosing and Rx systems
Nutrition and Wellness systems
Ventilator management systems
Anesthesia systems
Sterilization and asset workflow systems
Enroute (to medical facility) support systems
Flight for life, ambulance
Fetal monitor displays
Echo cardiogram displays
Medical data merged from numerous systems
Custom interfaces for medical devices and clinical information systems
Smart phone, PDA, iPad apps (Mobile Medical Apps)
QMR - MDDS Solution Steps
1. Conduct a Product Classification Assessment
Are your systems MDDS, MDDS+, not MDDS?
2. Register and List MDDS devices
3. Conduct Quality System Gap Assessment
Depending on the existence of MDDS or higher
Risk based
4. Write a Quality System (QS) Implementation Plan
Identify staff, establish budget and timeline
Prepare to meet or beat April 18th, 2012
5. Execute the QS Implementation Plan
Project team should minimally include:
Project Manager / Owner, QA, Regulatory/ Compliance, Clinical, Risk
Management, Information Technology, System Users
Why QMR
Regulatory professionals with expertise in:
Medical Device Data Systems Assessments (currently 7 projects)
Medical device and GxP information systems validation (20+ projects)
Device classification and reclassification
Implementing Quality Systems, labeling, medical device reporting and
other applicable FDA requirements
Considerable experience with mobile, wireless, wellness home health and
tele-health devices, including EMC/RF issues
Regulatory responsibility for Information Technology departments (20+
years)
Vendor management, including vendor selection for outsourcing critical
corporate compliance and decision support systems (20+ years)
AAMI/FDA MDDS Working Group committee member
Excellent relationships with key FDA personnel
Training for GxP, QSR, MDR, recalls, software validation, regulatory
awareness, risk management
510(k) submissions (35+)
Experience in VP, “C” level and Director roles in QA, IT, Regulatory, Compliance and Internal Audit
Technical resource team with expertise in all applicable disciplines